Skip to main content
OpenTrials
Completed

NCT Number: NCT04058548

Clinical Utility of the 1-minute Sit to Stand Test as a Measure of Submaximal Exercise Tolerance in Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation

The aim of this study is to assess whether the 1 minute Sit to Stand (STS) test can be used as a measure of submaximal endurance during a pulmonary exacerbation of Cystic Fibrosis (CF) for patients in the acute care setting. We hypothesize that if the STS test is a valid measure of submaximal cardiovascular endurance, it will moderately correlate with 6 minute walk distance (6MWD).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients age 6-35 with cystic fibrosis who are admitted for a pulmonary exacerbation and receive ongoing physical therapy throughout their admission.

Exclusion criteria

  • patients with cystic fibrosis who are under the age of 6,
  • patients with cystic fibrosis who are not admitted for a pulmonary exacerbation,
  • patients with cystic fibrosis who are not being followed regularly by physical therapy (>5x/week) throughout their inpatient admission,
  • patients with cystic fibrosis who are unable to follow instructions for standardized testing,
  • patients with cystic fibrosis who are not medically stable to participate in submaximal exercise testing.
  • patients whose inpatient admission is anticipated to be <1 week.
  • Patients who are readmitted to the hospital within the year will not be included in the study more than once.

Treatment and study plan

Sit to stand test

Diagnostic Test

Participants will complete a sit to stand test in addition to a 6 minute walk test

Other names: 6 minute walk test

Primary outcomes

  1. 1-minute STS repetitions:

    Time frame: 1 minute

    Number of STS completed

  2. 1 minute STS power:

    Time frame: 1 minute

    number of STS completed in 1 minute multiplied by bodyweight in pounds

  3. 6 Minute Walk Distance (6MWD):

    Time frame: 6 minutes

    total distance in feet completed during test

  4. 6MWT power

    Time frame: 6 minutes

    total distance in feet multiplied by bodyweight in pounds

Secondary outcomes

  1. Heart rate

    Time frame: 1 minute

    beats per minute

  2. Oxygen saturation

    Time frame: 1-6 minutes

    percentage via pulse oximetry

  3. Respiratory rate

    Time frame: 1-6 min

    breaths per minute

  4. Rating of perceived exertion

    Time frame: 6 minutes

    rating via Borg scale for perceived exertion: 0-10 with 0 being no breathlessness and 10 being maximal breathlessness

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 15, 2019
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.